CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Exemestane +1 moredrug
Likely dose
Exemestane and tamoxifen 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01831076
NCT01831076Phase 2Completed
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Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors. A Phase II Study to Identify Molecular Predictors for Hormone Responsiveness and/or Resistance.

University of Colorado, Denver·interventional·Posted Apr 15, 2013·Updated Mar 3, 2022

In Brief

A Phase 2 clinical trial evaluating Exemestane and Exemestane and tamoxifen for Breast Cancer and 2 related conditions. Completed, enrolled 36 participants across 1 site.

Detailed Summary

This phase II trial studies how well exemestane before surgery works in treating postmenopausal patients with newly diagnosed estrogen receptor positive stage II-III breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 15, 2013
Enrollment StartApr 1, 2002
Primary CompletionFeb 1, 2013
Study CompletionJan 6, 2022
TodayJul 2, 2026
Enrollment to primary: 10.8 yearsPosted 13.2 years ago

Interventions

Exemestanedrug

Given PO

Exemestane and tamoxifendrug

exemestane 25 mg po daily and tamoxifen 20 mg po daily given concurrently for 4 months prior to surgery